Thursday, 16 August 2018

*Professor of EU
law, University of Cambridge and PhD student, University of Cambridge. This
research has received support from the ESRC’s UK in a Changing Europe
programme.

The recent report
published by UK in a Changing Europe discussed different governance structures
that could potentially regulate UK-EU relations post-Brexit. The now published White
Paper provides insight into the sort of institutional framework the UK will
seek from the EU upon its withdrawal. Is there merit in the UK’s proposals? Are
there alternatives? We look into the options for the dispute resolution
mechanism post-Brexit.

Institutional arrangements

The White Paper
suggests that the governance of the UK-UK relations could be laid down in an association
agreement (AA). The agreement would provide an overarching institutional
structure which would cover the majority of the individual agreements for
different elements of economic, security and cross-cutting cooperation. The form
of economic cooperation is likely to be concluded in the form of a mixed free trade
agreement (FTA).

The White Paper
suggests governance through two main institutions:

-a Governing Body which would set
the general direction for the future relationship and,

-a Joint Committee which would be
directed by the Governing Body and would manage the implementation of the
relationship.

Member States will
be given authority through the Governing Body, which would consist of the heads
of states and the presidents of the EU institutions and would meet at least
biannually. Ad hoc meetings at ministerial level would also be held. The Joint
Committee would consist of officials from the EU and the UK. In addition, the
UK Parliament and the European Parliament would maintain a regular and formal
dialogue.

The overall
structure proposed in the White Paper is hybrid (see p. 21 of the report)
because Member States of the EU as well as EU institutions would have authority
in the governance of the relationship. This is different to other EU
association agreements where Member States do not have a direct role in the
supervision and implementation of the agreement. For example, under both the
EU-Ukraine AA and the EU-Moldova AA the Association Council plays a role
similar to that of the Governing Body. The Association Council consists, on the
EU’s part, of members of the Council of the European Union and members of the
European Commission. The structure of the EU’s AAs is commonly supranational
because representatives from the EU institutions rather than member states are given
the task of overseeing the implementation of the agreements.

Dispute resolution

The White Paper also
proposes a framework for dispute resolution between the parties to the AA. The
suggested mechanism would cover binding commitments between the parties, such
as trade obligations. Protection of private rights is not covered and so
British individuals or companies who consider their rights under the AA to have
been infringed would only be able to enforce their rights in the UK through the
UK courts and in the EU by the EU courts (para. 33 of the White Paper). This is
typical of the EU’s AAs. For example, Article 402 of the EU-Moldova AA also
excludes private rights from dispute resolution. The Comprehensive and
Progressive Agreement for Trans-Pacific Partnership (CPTPP), which replaced the
Trans-Pacific Partnership (TPP) when the US withdrew from negotiations last
year, also expressly excludes private action against the contracting parties
(Article 28.22).

Private rights are
also excluded from the dispute resolution mechanism under the Agreement on the
European Economic Area (EEA Agreement) between the EU and members of the
European Free Trade Area (EFTA) Norway, Liechtenstein and Iceland. To fill the
gap, the European Commission, on the EU’s side, and the EFTA Surveillance, on
the EFTA side, can receive complaints concerning the application of the EEA
Agreement (Article 109(3) of the EEA Agreement) and may impose a fine on
private persons if they breach the EEA Agreement (Article 110 of the EEA
Agreement).

The EU’s recently
concluded FTAs, such as the EU-Canada Comprehensive Economic and Trade
Agreement (CETA), establishes a separate mechanism for investor claims and
disputes arising in the financial services sector. Compensation awarded to
investors is the primary remedy for such claims. The White Paper does not
discuss this option. It is unclear whether the UK-EU FTA will contain an
investment protection chapter.

Dispute resolution body

The White Paper says
that disputes between the EU and the UK must be raised in the Joint Committee. Intermediation
by an executive body is common to dispute resolution under the EU’s AAs. For
example, under the EU-Moldova AA consultations are sought by sending a written
request to the other party, copied to the Association Committee in Trade
configuration (equivalent to a trade subcommittee of the Joint Committee). A
similar arrangement for filing trade disputes is provided in the EU-Ukraine AA (Article
306).

If negotiations
fail after a reasonable period of time, either of the parties may refer the
dispute to an independent arbitration panel. Dispute resolution by independent
arbitration panels is also typical in the EU’s AAs, including the EU-Moldova AA
(Article 385) and the EU-Ukraine AA (Article 306). State-to-state dispute
resolution under the EEA Agreement is different in this respect as it does not
provide for the establishment of independent arbitration and instead gives the
judicial function to an executive body (Article 111(2)).

The composition and
process for appointment of an arbitration panel are not laid down in the White
Paper, nor are the criteria for access to it, nor whether its findings will be
published. All that is known so far is that the panel would include members
from both parties. To this end, Article 28.9 of the CPTPP may serve as a
template as it provides detailed rules on the composition of panels.

Remedies

The White Paper
provides that in case of non-compliance, a complaining party may take measures
to mitigate harm caused by the breach. These measures may include financial
penalties or suspension of specific obligations (i.e. retaliation). As is
common with trade regimes such as the WTO and CETA, such measures must be
temporary and proportionate. Compensation and suspension of obligations for
violations of trade obligations is typical to the EU’s AAs and are provided in
both the EU-Moldova AA (Article 393) and the EU-Ukraine AA (Article 315).

In relation to
suspension of obligations, WTO law allows a complaining party to
cross-retaliate against any economic sector of the non-compliant state. In case
of non-compliance by the EU, the so-called ‘carousel’ principle applies – goods
and member states which are targeted by cross-retaliation rotate so that
consequences are not concentrated in one member state and with respect to one
product. The White Paper does not consider whether the same principle should apply
to the UK-EU relationship. It only notes that suspension of obligations should
be localised to the extent possible to the area of the future relationship that
the dispute concerned (para. 46 of the White Paper). This is likely to be
interpreted as meaning that in case of breach of trade obligations, suspension
of obligations should be limited to trade.

In sum, the dispute
resolution mechanism outlined in the White Paper is a mix of common features
found in other EU association agreements as well as some innovative features.
The proposal is up for negotiation with the EU, but it is Westminster rather
than Brussels that will likely subject the proposal to most intense scrutiny
and criticism.

The role of the CJEU

The influence of
the Court of Justice of the European Union (CJEU) over the judicial system of
the United Kingdom was, according to the Prime Minister, one of the key reasons
which led to the Brexit vote. The Government has repeated time and time again
that leaving the EU means leaving the jurisdiction of the EU Court. This has
been a government red line. Yet, both in her Florence speech delivered on 22
September 2017 as well as in her Mansion House speech of 2 March, Theresa May
suggested that judgments of the CJEU could be taken into account by the UK
courts to ensure consistent interpretation of relevant EU law. This particular
red line has already shown a pinkish hue.

So what exactly
does it mean to leave the jurisdiction of a court but take its judgments into
account?

Perhaps
intentionally, the White Paper does not provide a straightforward answer to
such a fundamental question. The document does suggest that the CJEU could have
a dual role post-Brexit: (1) in relation to the UK courts when enforcing
private rights stemming from the future relationship, and (2) in relation to
the state-to-state dispute resolution mechanism. This is different to the EU’s
recently negotiated FTAs, such as CETA where the CJEU has no role whatsoever.
It is, however, typical in the EU’s AAs, perhaps because the aim of AAs is to
lead to membership in the EU (this is not the case for economic cooperation
under the FTAs). What the White Paper does demonstrate is that the sloughing of
the CJEU skin is considerably more difficult than many Brexiters liked to
think.

Let us address the
dual role of the CJEU suggested in the White Paper.

The role of the CJEU in domestic cases

An obligation for
the UK courts to follow the CJEU’s case-law differs depending on whether the
dispute concerns the ‘common rulebook’ or other binding commitments under the
future agreements. A ‘common rulebook’ is a customs arrangement proposed in the
White Paper which effectively means that the UK would maintain the same rules
for trade in goods as those of the EU in order to maintain frictionless trade
and avoid Ireland/Northern Ireland border. It is not clear whether the UK
intends to update its rules in line with changes in EU law.

The White Paper also
suggests that when the UK courts enforce private rights stemming from
commitments other than those related to the common rulebook, they ‘could’ take
into account the relevant case law of the CJEU. This broadly confirms the
language of s.6(2) of the recently adopted EU
(Withdrawal) Act 2018 which provides ‘a court or tribunal may have regard
to anything done on or after exit day by the European Court … so far as it is
relevant to any matter before the court or tribunal.’

In addition, the
White Paper opens a backdoor to the CJEU’s case law. In case of ‘significant’
divergence between the interpretation of the agreements by the EU and UK
courts, the Joint Committee (the governing body for the future relationship) ‘could
be empowered to act to preserve the consistent interpretation’ (para. 34 of the
White paper). The practicalities of indirectly giving such unprecedented power
over domestic courts to an executive body are not detailed.

An obligation for
the UK courts to follow the CJEU’s case-law is stronger in relation to the
common rulebook: the UK ‘would’ commit to its courts paying due regard to the
CJEU’s case law. This effectively means that the CJEU’s interpretation of rules
governing trade in goods would be binding on UK courts. Neither the EU-Moldova,
nor the EU-Ukraine AAs set such obligation, perhaps because the EU does not
have a common rulebook with them. Instead, they commit themselves to
progressive legislative approximation, that is making their laws similar to
those of the EU. In the process of legislative approximation, due regard must
be given the case-law of the CJEU (e.g. Article 153 of the EU-Ukraine AA on the
approximation of public procurement rules) but that is different from directly
binding domestic courts to follow the CJEU’s case-law.

On the other hand,
the implementation of rights and obligations stemming from the EU-Turkey
Customs Union, in so far as they are identical to corresponding provisions
of EU Treaties, must be interpreted in conformity to CJEU’s case-law (Article
66 of Decision No 1/95 of the EC-Turkey Association Council). Unlike
association with Moldova and Ukraine which do not have a customs union with the
EU, Turkey must ensure that its trade policies are compatible with those of the
EU in order to maintain frictionless trade.

The UK courts would
not, however, be able to make a preliminary ruling to the CJEU to ask for the
CJEU’s interpretation on a certain aspect of EU law (para. 35 of the White
Paper). However, the draft Withdrawal
Agreement, which governs the UK’s exiting from the EU as well as matters
related to the transitional relationship (i.e. post 29 March 2019 until 31
December 2020), does allow EU citizens to ask UK courts to make a reference to
the Court of Justice. Article 151(1) of the Withdrawal Agreement states that
when dealing with cases concerning citizens’ rights which were commenced within
8 years from the end of the transition period, the UK courts will be able to
request the preliminary ruling (i.e. decision on interpretation) from the CJEU
(without the presence of a British judge). The time-limits of the transition
period are not (yet) known, but it may be extended for some years.

So, in answer to
the question, has the UK been set free from the CJEU, the answer must be: not
as much as many might like.

The role of the CJEU in dispute resolution between the
parties

The White Paper
also discusses resolution of disputes between the UK and the EU, as opposed to
cases in the UK courts enforcing private rights.

Disagreements
between the UK and the EU over the common rulebook for trade in goods would
have to be resolved consistently with the CJEU’s case law. The Joint Committee
(by mutual consent) or the arbitration panel would be able to make a
preliminary reference to the CJEU. The CJEU’s interpretation of points of EU
law would be binding on the Joint Committee and the arbitration panel (para. 42
of the White Paper).

This is not novel.
Article 403 of the EU-Moldova AA provides that the CJEU’s rulings are binding
on matters of EU law in disputes between the EU and Moldova (this would cover
the common rulebook). Similarly, Article 322 of the EU-Ukraine AA provides that
where a dispute raises a question of EU law, the arbitration panel must request
the CJEU’s ruling which would be binding on the arbitration panel.

The approach
adopted under the EEA Agreement is different. Reference to the CJEU is neither
mandatory nor automatic – only if the dispute has not been settled within three
months after it has been brought before the EEA Joint Committee, the parties
‘may’ agree to request the CJEU to give a ruling on interpretation of relevant
points of EU law (Article 111(3) of the EEA Agreement).

In sum, the degree
of influence of the EU Court over the UK’s judiciary will to a large extent
depend on how much EU law will be let into the domestic system: the deeper the
relationship, the bigger the role for the EU Court. A full stop to the
jurisdiction of the CJEU would be a reality in case of a ‘no deal’ Brexit, and
even in this situation the Withdrawal Act makes clear that the British courts
may still take account of the case law of the Court of Justice because given
the volume of EU law which is incorporated into UK law, the case law of the
Court will have influence for decades to come.

Wednesday, 15 August 2018

Dr hab Agnieszka Frąckowiak-Adamska,
Faculty of Law, University of Wroclaw

In case C-216/18
PPU LM the CJEU was asked by an
Irish court to address one of the most serious current legal challenges of the
EU: the consequences of restrictions imposed upon judicial independence in one Member
State for other Member States of the Union. The sequence
of laws adopted in 2015-2018 in Poland has been assessed commonly by
various external and internal institutions as “enable(ing) the legislative and
executive powers to interfere in a severe and extensive manner in the
administration of justice and thereby pos(ing) a grave threat to the judicial
independence as a key element of the rule of law” (quotation from the Venice
Commission). Consequently, to protect the rule of law in Europe, the
European Commission submitted for the first time in the history a reasoned
proposal activating the Article
7 TEU mechanism. Two infringement procedures based on Article 258 TFEU
against Poland are also ongoing (on the law on the ordinary courts organisation
- C-192/18
and on the law
on the Supreme Court). The Supreme Court itself has also asked the CJEU to
rule on the latter issue (see discussion here).

Is the organisation of the judiciary in Member States the
EU’s business?

The Polish reforms
are problematic for the EU because national courts are to ensure “the full
application of European Union law (…) and (…)judicial protection of an individual’s rights under that law” (Opinion
1/09, § 68). If politicians can influence courts’ decisions, they can
use this leverage to pursue sheer protectionism, instead of advancing the
interests linked to the EU internal market and citizenship. In addition, deficiencies
of judicial independence in one Member State entail problems for the courts in
other Member States, as the latter are obliged by EU law to recognize and
enforce judicial decisions coming from other EU Member States. Should the
courts trust the judgments from the State in which the division of powers is blurred?

Many questions arise
in this context. Member States and their legal orders differ as to the
substance and procedures, ways and level of protection of fundamental rights,
court organisation and the expediency of proceedings. These differences are
treated as diversity and have not prevented the EU from establishing the European
area of justice based on mutual trust and mutual recognition of judgments. How
to find the limits of States’ freedom to organise their judiciary? How to
differentiate between a “reorganisation” and a breach of the rule of law? Is
the EU (and if yes, who exactly – Council, CJEU?) legitimized to make such a
decision? And what consequences should be drawn if a breach of the rule of law is
established?

These issues can be
important for all 24 EU acts introducing mutual recognition of judgments (14
regulations on civil cases and 10 framework decisions and 2 directives on
criminal cooperation). The LM case
arose in the context of one of them – the European Arrest Warrant (EAW) Framework
Decision.

The preliminary reference in the LM case

In the Irish case,
in which the EAW was issued by a Polish judicial authority against a person
prosecuted for a drug related crime, the defendant argued that, due to the
reforms of the Polish judiciary, there is a risk of denial of justice if he is
transferred to Poland. Consequently, the Irish court premised its preliminary
question to the CJEU on the right to fair trial. As at this time Poland was
already subject to the stage of a reasoned proposal by the Commission as
referred to in Article 7(1) TEU (which would, if adopted by the Council,
have established a risk of a threat to the rule of law in Poland), the Irish
court asked whether in case of “cogent evidence that conditions in the issuing
Member State are incompatible with the fundamental right to a fair trial
because the system of justice itself in the issuing Member State is no longer
operating under the rule of law” it should “make any further assessment,
specific and precise, as to the exposure of the individual concerned to the
risk of unfair trial”. Such a two-prong test (first - “systemic deficiencies in
the state”, and second – “actual risk in an individual case”) was established by
the CJEU in the Aranyosi
judgment (discussedhere),
which also related to the protection of fundamental rights in the context of
mutual recognition of judgments, in the context of detention conditions.

In the LM case the CJEU could answer the
question in three different ways. First, it could refrain from assessing the
impact of the restrictions of judicial independence on the EAW mechanism (following
Poland’s argument that only the Council is empowered to do so, on the basis of
Article 7 TEU). Second, it could follow the Aranyosi
pattern, ie the two-step test. As the last alternative, it could allow to
suspend the cooperation with a Member State which breaches the obligation to
ensure the independence of its courts. This last possibility could seem all the
more likely path towards deciding the LM case after the Court issued its recent
decision in the case of
Associação Sindical dos Juízes Portugueses
(discussed here),
in para 37 of which it stated that the obligation of judicial independence stems
from the EU law.

Judgment in the LM
case

Maybe because of
time constraints (as the due urgent procedure applied) or maybe due to an
unwillingness of the CJEU to become dragged down into a political brawl, the
Luxembourg institution took the safest path of applying to the case the already
existing pattern (Aranyosi).

According to the
judgment of 25 July 2018 in the LM
case, national courts should apply both steps of the Aranyosi test when judicial independence in the issuing country is
endangered. If the executing court possesses a strong evidence of systemic or
generalised deficiencies in this respect, it should proceed to the second step
– of individual case assessment. The CJEU indicated that suspending the
mechanism of recognition is possible only if the decision on the basis of Art.
7 TEU is taken (§§ 71 -73 of LM).

Until this moment even
if a Member State is subject to a reasoned proposal, as referred to in
Article 7(1) TEU, “the executing judicial authority must refrain from
giving effect to the European arrest warrant” only if there are substantial
grounds for believing that that person will run a real risk of a breach of the fundamental
right to a fair trial (§ 78 and 59). However, there is one important novelty
(stemming from §§ 60 and 68 of LM) - the
fact of starting the Article 7 TEU procedure rebuts the presumption of mutual
trust as the individual assessment is required in every case in which the
person subject to EAW pleads it.

By the same token,
the Court found itself competent to tackle the issue of judicial independence, but
only from the perspective of the protection of an individual. It did not determine
any systemic consequences of limiting the judicial independence for judicial
cooperation. The issue of judicial independence was thus treated as a part of a
right to a fair trial protected by Article 47 of the Charter. The answer was
based on the interpretation of Article 1 (3) of the EAW framework decision,
which states that this act shall not modify “the obligation to respect
fundamental rights and fundamental legal principles as enshrined in
Article 6” [TEU] (nota bene
interesting from the Freudian perspective is that the CJEU did see in this
provision also the reference to Article 2 TEU (§ 45 of LM), which sets out the values of the EU enforced by the Article 7
process, even though Article 1(3) mentions only Article 6 TEU, which refers to
the mechanisms for the protection of human rights within the EU legal system).

The reasoning of
the court unfolds in three parts.

Firstly (§§ 33-46)
the CJEU reminds of the fundamental values and principles which are at stake in
the case – Article 2 TEU, mutual trust, and mutual recognition principles. Then
it confirms that the execution of the EAW constitutes a rule and can be refused
only when one of the grounds of refusal exhaustively listed by the Framework Decision
materialises. Additionally, the executing judicial authority has the power to
bring the surrender procedure to an end ‘in exceptional circumstances’, when limitations
are placed on the principles of mutual recognition and mutual trust.

In the second part (§§
47-59) the CJEU verifies whether a risk of a breach of the fundamental right to
an independent court can justify a limitation of the mutual trust and permit
the executing judicial authority to refrain from giving effect to an EAW. This highlights
the importance of judicial independence as a part of a right to fair trial and
the rule of law. It repeats the statements made by the Court in Associação Sindical dos Juízes Portugueses
i.a. that it is an obligation of Member States to ensure that their courts
which “come within its judicial system in the fields covered by EU law” meet
the requirements of effective judicial protection. Only if there is a real risk
that the person will suffer a breach of his fundamental right to an independent
tribunal and, therefore of the essence of the right to a fair trial, can the
executing judicial authority to refrain, by way of an exception, from giving
effect to the EAW (§ 59).

For national courts
and individuals the most important part of the judgment are paras 60-78, which instruct
the former on how to proceed if the person in respect of whom an EAW has been
issued pleads that there are systemic or generalized deficiencies in the
independence of courts in the issuing state. The procedure is not left to the
discretion of the executing authority. In such a case the executing authority
is required to make an assessment of the risk in the individual case (§ 60).
The assessment consists of two steps – a systemic assessment (§ 61-68) and a specific
one (§ 69-78).

The first step (a systemic
assessment) should be done by the executing authority on the basis of
“objective, reliable, specific and properly updated” information and according
to the criteria of judicial independence set out by the CJEU in §§ 62-67 of the
LM case. If this assessment implies
the conclusion that there is a real risk of systemic or generalised
deficiencies of judicial independence there, the court is obliged to pass to a
specific assessment. The executing authority does not have to make its own
assessment if the issuing state is subject to reasoned proposal as referred to
in Article 7(1) TEU, and “the executing judicial authority considers that
it possesses, on the basis, in particular, of such a proposal, material showing
that there are systemic deficiencies, in the light of those values, at the
level of that Member State’s judiciary” (§ 68). In such a case also the
executing authority should pass to the second step.

The second step
(specific assessment) aims to verify whether in the particular circumstances of
the case there are substantial grounds for believing that, following the surrender
to the issuing Member State, the requested person will run a real risk of a breach
of the fundamental right to a fair trial (§ 69-78). The court should verify
firstly “to what extent the systemic or generalised deficiencies are liable to
have an impact at the level of that State’s courts with jurisdiction over the
proceedings to which the requested person will be subject” (§ 74). In case of a
positive answer, it should assess whether there is a real risk of a breach of
his fundamental right to an independent tribunal, having regard to his or her personal
situation, the nature of the offence for which he or she is prosecuted and the
factual context that forms the basis of the European Arrest Warrant.

It can perform this
assessment on the basis of (§§ 75-78): 1) specific concerns expressed by the
individual concerned and any information provided by him or her; 2) any
supplementary information obtained from the issuing judicial authority in the
answer to the (mandatory) request made by the executing authority’; and 3) (optional)
assistance from the central authority or one of the central authorities of the
issuing Member State.

If the information
obtained in such a way by the executing judicial authority “does not lead the
latter to discount the existence of a real risk (…) (for the individual
concerned) “the executing judicial authority must refrain from giving effect to
the European arrest warrant” (§ 78).

Assessment of the LM
judgment

It is difficult to
assess the LM judgment in an unequivocal way (see the debate on Verfassungblog).
The Luxembourg court is praised by some for confirming its competence to tackle
the issue of the independence of judiciary and for its judicial prudence. It is
criticized by others for not setting systemic consequences of the breach of
independence but also for a definition of judicial independence which is too
detailed and disconnected from the ECHR’s.

Certainly, the LM judgment did not halt the Polish
“reforms”. Instead it allowed to rebut the presumption of mutual trust if a Member
State is subject to a reasoned proposal provided by Article 7(1) TEU. In
such a case the individual assessment is required in every case in which it is
pleaded. But it means that the executing authorities would have to make
embarrassing investigations about the substantial issues of the cases and of
the division of powers in Poland. In my opinion (developed here),
it can contravene the spirit of mutual trust between the courts and often will
be impossible in practice. Arguably the CJEU should have focussed not only on
the protection of individuals but also on the interests of other States and the
EU at large. In the LM case the CJEU acted
like the Court of Human Rights which is always very welcome. But it is not
enough to stand up against the destruction of the rule of law in Europe. Maybe in
next cases – either based on the Article 258 TFEU infringement procedure or following
the preliminary
reference from the Polish Supreme Court it will show also its other face –
this of a constitutional court of the EU.

But the LM judgment can also be seen as an
important development of the case law related to the protection of fundamental
rights in the context of mutual recognition. At least some questions arising after
the Aranyosi decision have been
answered. It is now clear that not only an infringement of Article 4 of the
Charter (on freedom from torture or other inhuman or degrading treatment, in
the context of detention conditions) but also of the essence of Article 47 (which
is always at stake when the judicial independence is limited) can justify
refraining from the execution of the EAW. However, it is to clarify whether the
EAW should not be executed also in case of the risk of the breach of further fundamental
rights e.g. a right to a private and family life. The detailed analysis on the
issue whether the right to the fair trial is capable of limiting the execution
of EAW (§§ 47-59) suggests that it is not certain that every right protected by
the Charter can have this effect.

Other aspects to be
clarified in the future are what “refraining from giving effect to the EAW”
exactly means and whether the systemic deficiencies are a prerequisite to apply
the individual test. The Aranyosi and
LM cases are related to systemic
deficiencies, but their conclusion is that what is always required to be
performed is the individual risk test. The development of the case law on
another aspect of the Area of Freedom, Security and Justice – the common European
asylum system – shows that the transfer of an asylum seeker to another Member
State should be refused if there is a risk of the person concerned suffering
inhuman or degrading treatment even if there are no systemic deficiencies (case
C-578/16
PPU, C.K., discussed here).
The open question is whether the same pattern will apply to the EAW and to
other fundamental rights.

My final point is
that the non-execution of EAWs based on an individual test is not capable to
resolve the essence of the problems with fundamental rights and judicial
independence. It often results in an impunity for the requested person, which
constitutes a severe consequence for others (victims) and for the public
interest. Moreover, it can save fundamental rights of individuals partly only. The
parallel judgment in Case C-220/18
PPU ML confirms this conclusion,
as it limits the meaning of the Aranyosi
assessment of detention conditions in the issuing Member State to the first prisons
in which the person concerned will be held immediately after the surrender. The
CJEU admitted that “since a person who is the subject of a European arrest
warrant can, as a general rule, be detained in any prison in the territory of
that State. It is generally not possible at the stage of executing a European
arrest warrant to identify all the prisons in which such a person will actually
be detained” (§ 81 of ML). In reality,
therefore, the individual is not wholly protected against inhuman treatment. The
same limitation is seen already in LM
judgment according to which the executing authority should verify “to what
extent the systemic or generalised deficiencies (..) are liable to have an
impact at the level of that State’s courts with jurisdiction over the
proceedings to which the requested person will be subject.” (§ 74 of LM).

The non-execution
of EAWs should be treated as a signal of serious problems and the EU should
reflect how to solve their sources. Here there is a clear difference between
prison conditions and the independence of the judiciary. In the case of a
breach of fundamental rights (Aranyosi)
the reason laying at the heart of the breach was a serious structural
incapacity of some Member States to ensure the proper standard of detention conditions
in prisons. Improving this capacity is a long, costly and complicated process,
which the EU could only stimulate and support. In the case of independence of
judges in Poland the source of the problem is the will of the governing party.
The problem could be very easily and quickly resolved by withdrawing the
reforms related to courts, according to the recommendations of the Venice
Commission/European Commission. The only thing that the EU can (and should) do
is to set clear limits as to the rule of law and the consequences of trespassing
them. If the EU had done it earlier addressing Hungary, the Polish government would
not have dared to follow the Hungarian path.

Monday, 13 August 2018

A recent CJEU judgment has made
it more complicated to develop plants which have been cross-bred by mutagenic
breeding. Two contributions to the blog (from Kathleen Garnett and Felix Beck) examine the judgment from different angles.

In September 2016 Stefan Jansson, professor in Plant Cell and Molecular
Biology at Umeå University in Sweden sat down to a meal of cabbage and
pasta, which he shared with a good friend. Prof Jansson had grown the cabbage
successfully in the back of his garden in Sweden using conventional
cottage-garden husbandry. He claimed it was a historic first – no one else on
planet earth (to the best of his knowledge) had ever eaten a CRISPR Cas-9 cabbage.
He obtained the mutagenic cabbage seed from a scientist abroad (who preferred
to stay anonymous).

Two years on and Prof Jansson
along with many of his colleagues in the scientific community are hugely
disappointed with the European Court of Justice’s ruling on mutagenic plants,
which came out on 25 July 2018. Commenting on his cabbage in Nature Jansson noted “I took a
photo yesterday, and I took another after the ruling. It’s still the same
plant. Yesterday it wasn’t a GMO, and now it’s a GMO. I’m a bit curious what I
have to do. Do I have to remove it?”

The CJEU’s ruling in the Confédération
Paysanne & Others case has led to derision within the scientific
community. Some have called the decision “catastrophic”, others “absurd". In this piece I set out the exact legal
reasoning of the judgment. Since this case concerns a very specific form of
plant breeding technique called “mutagenesis”, I briefly explain what is meant
by mutagenesis in order to place the case in context.

Background on transgenesis and mutagenesis

The two most common methods for
scientist to change the DNA structure of plants through artificial means are
transgenesis and mutagenesis.

Transgenesis occurs when scientists transfer a gene from
one species into the genome of another species. This happens through highly
sophisticated, scientific techniques, such as the use of a gene gun or through
the use of soil bacteria.

Cross-breeding between species
does not occur in nature. A dog cannot mate with a cat and produce off-spring
because they are from a different species. Similarly, in nature an apple cannot
cross-breed with a grass because of the species barrier. Species which are
closely related can produce off-spring but the off-spring are infertile – as is
the case with the mule.

Through transgenesis, however,
bio-engineers have been able to cross the species barrier by inserting the DNA
from one species into another species to produce crops with enhanced traits
that are capable of replicating. Transgenic techniques (although not defined in
the Directive as such) are described in Annex I A, Directive
2001/18 (the EU law on GM foods) as:

-recombinant nucleic acid techniques involving
the formation of new combination of genetic material by the insertion of nucleic acid
molecules produced by whatever means outside of an organism, into any
virus, bacterial plasmid or other vector system and their incorporation into
a host organism in which they do not naturally occur but in which they
are capable of continued propagation;

-direct introduction into an organism
of heritable material prepared outside the organism including micro-injection,
macro-injection and micro-encapsulation;

-cell fusion (including protoplast fusion) or
hybridisation techniques where live cells with new combinations of heritable
genetic material are formed through the fusion of two or more cells by means of
methods that do not occur naturally. (emphasis added in all cases).

In the US many maize, soya-beans,
corn and cotton seeds are grown using this technology. Over 40% of US
agricultural land cultivates transgenesis crops. In the EU there is only one
commercial variety of transgenesis
crop – the Mon 819 – which was approved in 1998 before the 2001
GMO Directive. Although cultivation of GMO crops in the EU is low to
non-existent the EU does, nevertheless, import huge amounts of GMO soya beans for
animal feed from over-seas.

Mutations, as some of us may
remember from our school biology classes, can occur spontaneously and randomly
in nature every few generations or so. Mutations can also occur spontaneously
as a result of background influences such as errors in DNA replication,
environmental chemicals and radiation. Since the 1960s a number of scientists
have been looking to induce rapid, unnatural mutation in plants in order to
improve certain plant characteristics by, for example, making citrus fruit
sweeter, with fewer seeds and thinner skins as with the KinnowLS.

I would like to stress at this
stage that “mutant” plant is the scientific term for these particular novel
plants. It is not an attempt to use alarmist terminology for the sake of a
“click-bait” headline. It is the official term used for these novel plants by
scientists themselves. Indeed, the international organisation responsible for
cataloguing these novel plants (the FAO/IAEA) refers to its list of mutagenic
plants as “The Mutant Variety
Database” with applicants asked on the registration form to list their new
“mutant” variety.

Conventional mutagenesis

In 2001 mutagenesis relied on two
primary methods to induce rapid, forced, plant mutation: the use of mutagenic
chemicals, or the application of ionizing radiation. For the purposes of this
piece I shall refer to these two specific forms of technology as “conventional”
mutagenesis.

When the GMO Directive was
drafted the EU opted to exempt conventional plant mutagenesis from the
Directive (2001/18/EC, Annex 1 B), presumably because it was a form of
technology that has been “conventionally used” and has a “long safety record”
(recital 17, Directive 2001/18/EC). As the Flemish Institute for Biotechnology states, conventional, in
vito, mutagenesis creates thousands of mutant plants the vast majority of which
are useless in that they either show undesirable product defects or are simply
non-viable. Only a few new plants bred out of conventional mutagenesis show
enhanced traits. It is the latter group of mutant plants which, in 2001 were
exempted from the GMO Directive. For the past 17 years those working on
classical mutagenesis have placed over 46 varieties of mutant herbicide
resistant sunflower and six varieties of mutant herbicide resistant rape seeds
on the EU catalogue
of common plant varieties without having to undergo the stringent risk
assessment procedures set out in the GMO Directive.

Novel mutagenesis

In the past decade, technological
advances in mutagenesis have ensured that the technology no longer relies on
either mutagenic chemicals or ionising radiation to affect artificial mutation
in plants. A number of novel, directed and very precise technologies have
emerged in the field of mutagenesis, which include:

An amateur gardener’s shed may have
a paint brush with which to brush the pollen from one plant onto the pistil of
a sexually compatible plant, producing a hybrid that carries genes from both
parents. In the case of novel, directed mutagenesis, however, this would be
impossible. It requires highly sophisticated scientific technique to create a
novel seed using these methods. No hobby, amateur gardener would have the
sophisticated equipment needed to create a CRISPR Cas-9 cabbage seed. The eye
alone is unable to distinguish the difference between a CRSIPR Cas-9 cabbage on
the one hand and a natural, conventional cabbage on the other – only scientists
using specialized DNA profiling would be able to identify the difference. Thus,
although growing plants from mutagenic seeds can be done in a traditional,
conventional manner (as Prof Jansson proves) the production of the seed is all
but traditional or conventional.

Questions referred to the CJEU

In 2015 a small, not-for-profit
organisation Confédération Paysanne together with eight other associations
concerned with the protection of the environment and the dissemination of GMO
information asked the then French Prime Minister to ban the cultivation and
marketing of herbicide tolerant rape varieties created through the use of
classical mutagenic techniques. Advocate General Bobek summarises the applicant’s concerns
as follows:

“For the
Applicants the use of herbicide resistant seed varieties obtained by
mutagenesis carries a risk of significant harm to the environment and to human
and animal health. It leads to an accumulation of carcinogenic molecules or
endocrine disruptors in cultivated plants intended for human or animal
consumption. The applicants refer, moreover, to the risks of unintentional
effects, such as undesired or off-target mutations on other parts of the
genome. They consider that this is the result of the techniques employed when
modifications of the genome takes place in vitro and for the regeneration of
plants from the cells thus modified.”

The French Prime Minister refused
their request, so the applicants appealed to the French Conseil d’État. Feeling
that this was a matter of EU interpretation the Conseil d’État referred the
case to the CJEU asking, in summary, whether plants created as a result of
novel, directed mutagenesis (i.e. those developed post 2001):

-fall under the definition of a GMO as set out in
Article 2, Directive 2001/18/EC, Article 2(2) Directive 2001/18 defines
"genetically modified organism (GMO)" as “an organism, with the
exception of human beings, in which the genetic material has been altered in a
way that does not occur naturally by mating and/or natural recombination”;

-are exempted from the impact assessment and
traceability measures required of transgenic GMO’s in Directive 2001/18/EC; my
review in this post focuses on these first two questions which have caused most
controversy in the scientific community;

-constitute GMO’s within the meaning of Article 4
of the Directive 2002/53/EC establishing a European common catalogue of
agricultural plant species varieties;

-constitute a harmonising measure prohibiting
member states to all or some of the obligations laid in the GMO Directive – or
do member states have some discretion to set the regime for organisms obtained
by mutagenesis; and

In January of this year A.G. Bobek
took a narrow interpretation of the GMO Directive. He agreed that novel,
directed mutagenesis techniques fall under the definition of a GMO (Opinion at
para 56) - but they are nevertheless exempted from the precautionary principle
and the other stringent requirements set out in 2001 by virtue of the Annex I B
exception (at para 56 and at para 81).

In Bobek’s opinion, the EU
intended to exclude all forms of mutagenesis from the GMO Directive - past,
present and future. Bobek opined that in
2001 the EU understood that technology does not stand still and that its
decision to exempt “mutagenesis” from the Directive’s obligations would apply
to all future mutagenic technology regardless of novel techniques.

“The
Applicants and several other interested parties have, to a great extent, relied
on recital 17 to reach the conclusion that the EU legislature only intended to
exempt safe mutagenesis techniques. I cannot agree. Neither the text, nor the
historical context, nor the internal logic of the GMO Directive supports that
proposition.” (at para 90 and at para 91).

The GMO Directive referred to
transgenic GMOs only through Annex I A and as such it is only that sort of
plant breeding to which the Directive applies. Had the intention in 2001 been
to include all new plant breeding techniques in the Directive’s stringent
obligations and requirements, the legislature would not have created the Annex
I B exemption referring specifically to mutagenesis. In short, all mutagenic
plants – both conventional and novel are exempt from the stringent requirements
set out in the 2001 GMO Directive. As a result, mutant plants could be placed
on the European catalogue of common agricultural plant varieties without the
need for applying the GMO requirements set out in the Directive establishing
the catalogue. In answer to the harmonisation question Bobek stated that the
2001 GMO Directive does not preclude member states from adopting measures
governing mutagenesis, provided that, “in so doing they respect the overarching
obligations arising from EU law.” (para 108 ff; sufice to say the CJEU agreed
with this part of the Opinion).

The CJEU judgment diverged
significantly from that of Bobek’s opinion.

The CJEU ruled:

“Article 2(2)
of Directive 2001/18 must be interpreted as meaning that organisms obtained by
means of techniques/methods of mutagenesis constitute GMO’s within the meaning
of that provision.” CJEU, Judgment, 25 July 2018, C-528/16, (para 54).

To recall, the 2001 Directive on
the deliberate release into the environment of GMO’s defines a GMO as “…an
organism, with the exception of human beings, in which the genetic material has
been altered in a way that does not occur naturally by mating and/or
naturalrecombination.” Article 2 (2)
Definitions 2001/18/EC.

Applying this definition to both
transgenic and mutagenic techniques the CJEU rules. “…those techniques/methods alter
the genetic material of an organism in a way that does not occur naturally,
within the meaning of that provision. It follows that organisms obtained by
means of techniques/methods of mutagenesis must be considered to be GMOs within
the meaning of Article 2 (2) of Directive 2001/18” (CJEU, para 29-30). (Emphasis added).

The CJEU further decided that
although mutagenesis is not listed as a GMO in Annex I A this does not mean
that novel, directed mutagenic techniques should not fall under the definition
of GMO’s. The use of the word “inter-alia” in Annex I A suggests “the list of
genetic modification techniques in that part is not exhaustive. Consequently,
the list cannot be regarded as excluding genetic modification techniques other
than those to which it specifically refers.” (CJEU, para 35).

“…only
organisms obtained by means of techniques/methods of mutagenesis which have
conventionally been used in a number of applications and have a long safety
record are excluded from the scope of the directive.” (CJEU, para 54).

Here the CJEU turns to the
Article 3(1) exemptions listed in Annex I B.

Firstly, the mutagenic exemption
must be interpreted strictly. The Court here refers to its finding in Białowieża Forest (Commission v Poland) C-441/17,
which itself builds upon a trail of precedent in the application of the
Habitats Directive. Arguably the first in that line of authority, Case C-239/04
Commission v Portugal, at 35 simply
observes the need for strict interpretation of exemptions from general
protective regimes. However, it would not be far-fetched to say that the
general principles of EU environmental law, in particular the principle of high
level of environmental protection and the principles of prevention and
precaution, play a role in that approach.

The need for strict
interpretation having been established, the Court still required further
guidance on how exactly that interpretation is to proceed. The wording of the
provisions evidently serves as a first guidance principle. Here, the Directive
is not of much help: at 43: the wording of Article 3(1) read in conjunction
with the Annex does not on its own provide any conclusive guidance as to the
types of techniques /methods that the EU legislature intended specifically to
exclude from the scope of the Directive.

Consequently, the CJEU decides to
examine the exemption contextually: ex multi: Pinckernelle, C-535/15. The context in which the exclusion is made
is clarified in particular by recital 17 of the Directive, which states
verbatim ‘this Directive should not apply to organisms obtained through certain
techniques of genetic modification which have conventionally been used in a
number of applications and have a long safety record.’ It is not at all
surprising therefore that the Court does not extend the exemption to those
techniques which do not so qualify: at 47: ‘the referring court is called upon
to rule, in particular, on the techniques /methods of directed mutagenesis
involving the use of genetic engineering which have appeared or have been
mostly developed since Directive 2001/18 was adopted and in respect of which
the risks for the environment or for human health have not thus far been
established with certainty.

The Court further notes at para
48 that what these techniques purport to do must be taken at face value:

‘…the direct
modification of the genetic material of an organism through mutagenesis makes
it possible to obtain the same effects as the introduction of a foreign gene
into that organism and, secondly, that the development of those new
techniques/methods makes it possible to produce genetically modified varieties at a
rate and in quantities quite unlike those resulting from the application of
conventional methods of random mutagenesis.’ (emphasis added)

This is then where the
precautionary principle firmly kicks in, again with reference to the recitals
of the Directive: at 49:

…living
organisms, whether released into the environment in large or small amounts for
experimental purposes or as commercial products, may reproduce in the
environment and cross national frontiers, thereby affecting other Member
States. The effects of such releases on the environment may be irreversible. In
the same vein, recital 5 of that directive states that the protection of human
health and the environment requires that due attention be given to controlling
risks from such releases.

At 50:

‘Furthermore,
it has been emphasised, in recital 8 of that directive, that the precautionary
principle was taken into account in the drafting of the directive and must also
be taken into account in its implementation. Emphasis is also placed, in
recital 55 of Directive 2001/18, on the need to follow closely the development
and use of GMOs.’

The Court need not but repeats at
50 the perfectly logical chain of interpretation that leads to its conclusion:
recital 17 explicitly justifies the exemption for mutagenesis by referring to
the safety record of conventional mutagenesis. Article 4(1) emphasises the
precautionary approach; such approach cannot support inclusion in the exception
for new techniques/methods of mutagenesis which have appeared or have been
mostly developed since Directive 2001/18 was adopted.

The impact of the Judgment

The ruling is significant for
many reasons, primarily because the Directive is no longer restricted to the
insertion of foreign DNA into the genome of a living species using the transgenesis
technique. Any artificial modification of a plant using novel, directed mutagenesis
must also apply the stringent obligations and requirements set out in Directive
2001/18.

Secondly, the terminology used in
the ruling opens up the door to many unanswered legal questions. There is
enough meat in this judgment to conclude that its reasoning extends not just to
transgenic and mutagenic plants but to all forms of novel plant breeding
techniques, which are likely to emerge in the foreseeable future.

Consider, for example, the
repeated references in Confédération
Paysannes to “naturally occurring”, “conventional use”, “at a rate and in
quantities quite unlike those resulting from the application of conventional
methods” and “long safety record”. The CJEU is at pains to point out that these
are not unimportant words to be dismissed as irrelevant when determining the
Annex I B exemption. Rather, the judges rule that these terminologies have
deliberately and intentionally been woven into the very fabric of the 2001
Directive in order to distinguish them from novel, artificial techniques.

Along these lines, some argue,
not unreasonably, that the law should apply to conventional mutagenesis itself
(the very technique the Directive and this judgment does exempt) given that the
use of mutagenic chemicals and ionising radiation is hardly a “naturally
occurring” technique albeit in 2001 it was considered “conventional”. All of
this begs the question how much Confédération
Paysannes will apply to other novel plant breeding techniques which are
sure to emerge in the coming years? If yes, is it even possible to define what
is meant by “conventional use”?Does
conventional use refer to ten years, twenty years or five months? If the law
understands what “naturally occurring” means is it possible to deduce a
definition of “artificial”, “induced” and “forced” technique? All of these
considerations could have wider implications on the commercialisation of the
EU’s biotechnology policy in the months and years ahead.

Further, unlike AG Bobek, who
took a very narrow interpretation of the Annex I B exemption, the CJEU took a
far broader approach to the questions referred to it by the Conseil d’Etat.
They did so by placing greater emphasis on the Directive’s over-arching
objective namely to protect human health and the environment. By focusing on
the potentially “irreversible” effect of the release of a mutant plant in the
environment the CJEU pulls the law on mutagenic plants – potentially all new
plant breeding techniques – firmly back into the orbit of the Directive’s
original intention and purpose namely to protect human health and the
environment from the unforeseen effects of GMO technology through application
of the precautionary principle.

Comments

It should be stressed that the
ruling does not stop researchers from continuing to research new plant breeding
techniques. They are, however, required to do so in a regulated, controlled
environment. Nor, does the ruling end all scientific endeavour in new plant
breeding techniques. The risk assessment obligations set out in the Directive
are not about gut-feeling. They ensure objective, impartial and transparent
scientific analysis. “The environmental risk assessment should be carried out
in a scientifically sound and transparent manner based on available scientific
and technical data.” (Annex II Principles for the Environmental Risk Assessment
B, 2001/18/EC). Prof. Jansson’s Plant Cell and Molecular Biology Department at
Umeå University in Sweden will still be able to conduct research into plant
mutagenesis – but probably not in a Professor’s back garden.

What the ruling does impact on,
however, is the ease with which industry can commercialise novel, mutagenic
plants in the EU. I would like to re-emphasise at this point that this ruling does
not block the cultivation of these plants on European Union soil. In practice
however, very few GMO varieties are grown in the EU given that industry
seemingly finds the obligations too stringent to invest the time, effort and
money in wanting to do so. Even in cases where industry has had varieties go
through the whole process, some of them have been subject to national
moratoriums in application of the ‘safeguard measures’ set out in Directive
2001/18/EC.

Taking the CRISP Cas-9 cabbage
grown in Prof. Jansson’s back garden as an example of the challenges facing the
commercialisation of mutagenic plants in the Europe: any CRISPR Cas-9 cabbage will
now be subject to notification to the national competent authority, using a
standard authorisation procedure. Environmental risk assessment must be carried
out, any risks must be managed, and any further growing must be subject to
regular inspections from national competent authorities. Keeping the seed
supplier anonymous, for instance, clearly will no longer be possible. Two days
after the ruling Bayer and BASF announced that they would pursue
gene-editing of plants outside of the EU.

For those wishing to
commercialise novel plant breeding techniques unchecked, this ruling is indeed
a set-back. For consumers in the EU, already enjoying a wide variety of fresh
produce, the immediate effects of this judgment seem less pressing.

To be or not to be… a regulated
GMO: The CJEU’s verdict on genome editing

Felix Beck, Doctoral candidate, University of Freiburg/Germany

The recent CJEU judgment on the
regulation of genome-edited crops has been debated heatedly throughout the
European Union. Many scientists and plant-breeders condemned the verdict as a
“backward step” and “hostile to progress“, while GMO sceptics hail it as
upholding the precautionary principle and protecting consumer choice between
GMO and non-GMO products. However, the legal reasoning of the Court has so far
only received little attention. While the Court was rather tight-lipped on the
biggest legal issues, the ruling still yields some interesting observations.

To recall the facts of the case:
On referral by the French Conseil d'Ètat, the CJEU had to decide whether crops
modified with so-called “genome editing” techniques are covered by the EU’s
Directive 2001/18/EC on the deliberate release of Genetically Modified
Organisms (GMOs). The notion “genome editing” refers to recently-developed
techniques, like CRISPR, that allow for targeted modification of the DNA of
virtually any organism. This allows to activate or knock-out specific genes,
for example to render a crop plant more resistant to certain herbicides or
pathogens. In contrast to conventional genetic engineering, genome editing is
much more precise and can be used without necessarily inserting foreign DNA
into the organism. Whether organisms resulting from these techniques are
subject to the protracted GMO regulation in the EU or not has been
controversial for several years.

First, the Court assumed with
much ado that genome edited organisms constitute GMOs in terms of Art. 2(2) of
Directive 2001/18/EC. It even saw no reason to comment on the controversial
question whether the notion “altered in a way that does not occur naturally”,
which is used to define what constitutes a GMO, relates to the technique of
genetic modification or its result. This question was not expressly presented
by the referring court, which allowed the CJEU to avoid taking a clear stand.
However, the Court indicated that it prefers a strictly process-oriented
interpretation, which means that any technique where the genome is modified in
vitro would lead to GMOs in terms of Directive 2001/18/EC.

The second and more difficult
issue concerned the question whether genome edited organisms are exempted from
regulation as organisms resulting from “mutagenesis”. Conventional mutagenesis
techniques rely on exposing the organism to certain chemicals or ionizing
radiation, which increases the occurrence of genetic mutations. Afterwards, a
plant breeder has to select individuals carrying the desired traits from a
large number of treated organisms. Pursuant to Art. 3 and Annex I B para. 1 of
Directive 2001/18/EC, organisms bred with “mutagenesis” are perceived to
constitute GMOs, but are exempted from the directive's scope. The term mutagenesis,
however, is not further defined or qualified under EU law, which posed the
question whether this term is to be interpreted dynamically (incorporating new
mutagenesis techniques) or whether it only refers to those mutagenesis
techniques that were known in 2001 when the Directive was adopted.

For the Court, the decisive
argument was recital 17, which provides that the Directive “should not apply to
organisms obtained through certain techniques of genetic modification which
have conventionally been used in a number of applications and have a long
safety record”. In the view of the Court, targeted mutagenesis techniques
simply have no such long safety record and thus do not fall under the
mutagenesis exemption.

In my view, this is a legitimate
way of reasoning. There is a difference between the generic meaning of
mutagenesis (i.e. any method that induces genetic mutations) and the legal
meaning of the same term: recital 17 of Directive 2001/18/EC clearly indicates
that only those techniques that were known and conventionally used when the
Directive was adopted in 2001 should be exempted from its scope, i.e.
conventional mutagenesis techniques relying on chemicals or radiation.
Otherwise, changes in scientific nomenclature would be able to modify the scope
of regulatory regimes, which would raise questions for the democratic
legitimacy of such an interpretation.

Importantly, and this appears to
remain difficult to grasp for non-lawyers, the Directive does not leave room
for the question whether targeted mutagenesis is equally safe or even safer
than conventional mutagenesis; it simply has no comparably "long"
safety record. Therefore, it was reasonable for the CJEU to reject the idea of
adopting a dynamic interpretation of the term mutagenesis, as Advocate General
Bobek suggested in his opinion.

Unfortunately, the CJEU judges
did not confine themselves to legal arguments, but also relied on very general
(and unsubstantiated) allegations that the risks associated with genome editing
were similar to those of conventional GM techniques (which is disputed by the
vast majority of scientists), and that genome editing would lead to the
development of modified organisms at higher rates and quantities (which is
true, but not a risk per se). These misguided statements may make it very hard
for scientists to accept that the CJEU's judgment may be okay from a purely
legal viewpoint.

After all, the CJEU never was the
appropriate organ to assess the risks or non-risks associated with genome
editing techniques or to decide on their future regulation. This is
fundamentally a matter of policy and must be dealt with by the European Union legislator.
Hence, the Court should not be blamed for choosing one out of two controversial
options for interpreting the Directive, but it should rather be asked why the
European Union legislator has remained inactive for so long. When the European
Commission proposed the first Deliberate Release Directive in 1988 and its
revision that was adopted in 2001, it promised to regularly update the
Directive in order to “keep pace with scientific and technological progress”.
It is time for the European legislator to live up to this promise.